BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2760275 · Received September 26, 2012

    Report

    Report Number
    1823260-2012-04825
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 17, 2012
    Report Date
    November 26, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. CALLER WAS UNSURE WHICH AVIVA NANO PRODUCED THE DISCREPANT RESULTS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. CALLER WAS UNSURE WHICH AVIVA NANO PRODUCED THE DISCREPANT RESULTS. REFERENCE (B)(4) FOR THE ADDITIONAL SUSPECT DEVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA NANO SYSTEM WITHIN 10 MINUTES: 3.9 MMOL/L, 1.0 MMOL/L, AND 9.0 MMOL/L. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 490892

    Patients

    Seq Age Sex Outcome Treatment
    1 004 YR "HUMALOG INSULIN LESS THAN 10 UNITS"| "LEVEMIR INSULIN LESS THAN 10 UNITS"| "NPH INSULIN LESS THAN 10 UNITS"